Clinical Trials Manager

Found in: Talent AU C2 - 2 weeks ago

Adelaide, Australia SAHMRI Full time

Summary

Part-Time (0.6FTE), 3-Year Fixed Term Contract

Situated within the Adelaide Biomedical Precinct, the SAHMRI Clinical Trials Platform (CTP) provides professional services and support for researchers and industry sponsors who need assistance at any stage of the clinical trials lifecycle. Established in 2021, the CTP is a growing team of Clinical Research Coordinators, Project Managers and Clinical Research Associates providing site and Academic Research Organisation (ARO) services for industry funded and investigator led clinical research.

SAHMRI are seeking a Clinical Trials Manager to lead the management and expansion of the CTP clinical trials/studies portfolio while working collaboratively with the leadership team to nurture growth and future prospects.

About the role

Key responsibilities include:

Clinical Research Management

Oversee the CTP operations, including study portfolio planning, budget development and monitoring, and resource allocation. Represent the CTP and liaise with stakeholders, as necessary. Negotiating and overseeing clinical trial contracts/ budgets. Contribute to portfolio development, strategic planning, and adherence to regulatory guidelines. Provide expertise on clinical projects and ensure adherence to best practices

New Business Development and Strategic Partnerships

Work with the SAHMRI Business Development Manager to engage, build, and maintain relationships with research partners and build links with potential clients. Identify new business opportunities, partnerships, and collaborations with commercial and academic clients including other Contract Research Organisations and local health networks. Participate in client meetings, presentations and negotiations. Collaborate within SAHMRI to ensure that proposals and contracts are aligned with CTP capabilities and client needs

Quality, Safety and Research focus

Direct CTP quality improvement initiatives, demonstrating a dedication to identifying and enhancing processes. Pursue ongoing professional development opportunities to expand expertise in research methodologies, including attending conferences and workshops. Oversee implementation of CTP Quality Management System including the development, optimisation, and review of work instructions and standard operating procedures

Leadership

Contribute to the strategic planning and execution of CTP initiatives, ensuring alignment with organisational goals and efficient resource utilisation. Develop and maintain partnerships with internal and external stakeholders, ensuring robust communication and negotiation to advance the program's objectives.

About You

The successful candidate will possess the following key attributes:

Postgraduate qualifications or equivalent experience in clinical trial management. Proficiency in navigating complex clinical and research environments, including evolving interdependencies and technical content. Demonstrated expertise in clinical trial design, data management, and regulatory compliance. Ability to work with multidisciplinary teams to achieve project milestones and develop and manage budgetary plans effectively. Excellent interpersonal, written, and verbal communication skills for effective stakeholder management and relationship building. Ability to analyse and solve problems and to deal with complex issues with an elevated level of critical thinking, sound decision making and attention to detail. A commitment to quality and the ability to work autonomously, prioritise tasks, and meet deadlines in a dynamic environment. Strong understanding of the clinical study process, ICH-GCP and relevant local regulations and quality principles for conducting clinical research.

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